Search by Drug Name or NDC

NDC 00363-0621-02 Anti-Itch 5; 2 g/100g; g/100g Details

Anti-Itch 5; 2 g/100g; g/100g

Anti-Itch is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is BENZOCAINE; RESORCINOL.

Product Information

NDC	00363-0621
Product ID	0363-0621_d6280ea7-ddfd-a97d-e053-2a95a90a407d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Anti-Itch
Proprietary Name Suffix	Regular Strength
Non-Proprietary Name	Benzocaine and Resorcinol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	5; 2
Active Ingredient Units	g/100g; g/100g
Substance Name	BENZOCAINE; RESORCINOL
Labeler Name	Walgreens
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00363-0621-02 (00363062102)

Pricing Information	N/A
NDC Package Code	0363-0621-02
Billing NDC	00363062102
Package	1 TUBE in 1 CARTON (0363-0621-02) / 28 g in 1 TUBE
Marketing Start Date	2020-01-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 64bc4ad7-4081-4f0e-9642-8e86705356d1 Details

Active ingredients

Benzocaine 5%

Resorcinol 2%

Purpose

External Analgesic

Use

Temporarily relieves itching

Warnings

For external use only

Avoid contact with eyes

Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Do not apply over large areas of the body.

Do not use if allergic to any of the ingredients

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12 years and older

apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.
clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses.

children under 12 years

consult a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe barbadensis leaf extract, carbomer, cetyl alcohol, cholecalciferol, glyceryl stearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, retinyl palmitate, sodium hydroxide, sodium sulfite, tocopheryl acetate, trisodium HEDTA, water

Questions or comments

1-800-WALGREEN (1-800-925-4733)

Principal display panel - 28 g Carton Label

NDC 0363-0621-02

REGULAR STRENGTH

Anti-Itch Cream

Pain Relieving Cream

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ANTI-ITCH REGULAR STRENGTH

benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0621
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5 g in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM SULFITE (UNII: VTK01UQK3G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRISODIUM HEDTA (UNII: K3E0U7O8KI)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0621-02	1 in 1 CARTON	01/09/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	01/09/2020

Labeler - Walgreens (008965063)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(0363-0621)

Revised: 1/2022

Document Id: d6280ea7-ddfd-a97d-e053-2a95a90a407d

Set id: 64bc4ad7-4081-4f0e-9642-8e86705356d1

Version: 2

Effective Time: 20220122